1. Field of the Invention
This invention relates to methods and apparatus for closing apertures in human and animal tissue and to methods and apparatus for inserting apparatus into such tissue to perform such closure functions.
2. Description of the Prior Art
During certain types of vascular surgery, catheters are inserted through an incision in the skin and underlying tissue to access the femoral artery in the patient""s leg. The catheter is then inserted through the access opening made in the wall of the femoral artery and guided through the artery to the desired site to perform surgical procedures such as angioplasty or plaque removal. After the surgical procedure is completed and the catheter is removed from the patient, the access hole must be closed. This is quite difficult not only because of the high blood flow from the artery, but also because there are many layers of tissue that must be penetrated to reach the femoral artery.
Several approaches have used to close femoral access holes. Typically, manual compression by hand over the puncture site can be augmented by a sandbag or weight until the blood coagulates. With this approach it can take up to six hours for the vessel hole to close and for the patient to be able to ambulate. This increases time for the surgical procedure as well as overall cost of the procedure since the hospital staff must physically hold pressure and the patient""s discharge is delayed because of the inability to ambulate. This is not an efficient use of either the patient""s or staff""s time. After some procedures, to close the vessel puncture site a clamp is attached to the operating table and the patient""s leg; The clamp applies pressure to the vessel opening. The patient must be monitored to ensure the blood is coagulating, requiring additional time of the hospital staff and increasing cost of the procedure.
To avoid the foregoing disadvantages of manual pressure approaches, suturing devices have been developed. One such suturing device, referred to as xe2x80x9cThe Closerxe2x80x9d and sold by Perclose, advances needles adjacent the vessel wall opening and pulls suture material outwardly through the wall adjacent the opening. The surgeon then ties a knot in the suture, closing the opening. One difficulty with this procedure involves the number of steps required by the surgeon to deploy the needles, capture the suture, withdraw the suture, and tie the knot, and cut the suture. Moreover, the surgeon cannot easily visualize the suture because of the depth of the femoral artery (relative to the skin) and essentially ties the suture knot blindly or blindly slips a pre-fabricated knot into position. Additionally, the ability to tie the knot varies among surgeons; therefore success and accuracy of the hole closure can be dependent on the skill of the surgeon. Yet another disadvantage of this suturing instrument is that the vessel opening is widened for insertion of the instrument, thus creating a bigger opening to close in the case of failure to deliver the closure system.
It would therefore be advantageous to provide an instrument which quickly and accurately closes holes in vessel walls. Such instrument would advantageously avoid the aforementioned time and expense of manual pressure, simplify the steps required to close the opening, and avoid widening of the opening.
The present invention overcomes the disadvantages and deficiencies of the prior art by, in one of its aspects, providing clip apparatus for closing a lumen aperture, particularly a vascular aperture, resulting from insertion of a surgical implement subsequent to completion of an invasive therapeutic procedure and withdrawal of the implement from the aperture where the apparatus includes an elongated strand comprising a central portion together with extremity portions extending from the central portion. The apparatus further involves tips of the extremity portions remote from the central portion being shaped to retain aperture peripheral tissue encountered thereby with the extremity portions having memory characteristics seeking to cause the extremity portions to curl towards and over one another about the central portion when the strand is in an unconstrained disposition, free of externally applied stress. Preferably, the apparatus is deployed in a two stage operation whereby the clip apparatus is initially deployed partially from a delivery apparatus with tips of the extremity portion contacting and the penetrating the interior surface of tissue of the vessel and acts to draw the aperture closed. In a second step the apparatus is fully dispensed from the delivery portion; tips of extremity portion of the apparatus do not penetrate the vessel tissue in the region about the aperture to be closed but act to draw the subcutaneous fascia on top of the outside aspect of the aperture. The two stage deployment of the closure apparatus results in a ratchet-type action by the deployment apparatus thereby providing extreme tactile sensitivity for the physician or other health professional handling the apparatus with resulting high sensitivity to the location of the apparatus and greater safety for the patient than otherwise possible.
In another of its aspects, this invention provides clip apparatus for closing a aperture, particularly a vascular aperture resulting from insertion of a surgical implement, into subsequent to completion of an invasive therapeutic procedure and withdrawal of the implement from the resulting aperture. In this aspect of the invention, the apparatus includes a plurality of elongated strands with each strand including a central portion and extremity portions extending from the central portion. Tips of the extremity portions remote from the central portion are shaped to retain aperture peripheral tissue encountered thereby. The extremity portions have memory characteristics seeking to cause the extremity portions to curl towards and about the central portion when the strand is in an unconstrained disposition, free of externally applied stress.
The clip apparatus may further include a band circumferentially enveloping the strands proximate the longitudinal midpoints of the strands for retaining the strand midpoints in close proximity to one another as the tip portions curl towards and about the midpoints. The band is preferably bonded to the strands.
The clip apparatus may further include a longitudinally elongated member extending from the central portions of grouped strands substantially in the longitudinal direction with respect thereto for facilitating gripping and guiding the strand portions of the clip member. The longitudinally elongated member is preferably rigid relative to the strand members.
In yet another of its aspects this invention provides a clip formed from a one piece integral strand, serving to close a lumen aperture such as a vascular aperture resulting from the insertion of a surgical instrument, where the clip includes an elongated strand of ribbon-like configuration having a central portion and extremity portions extending in opposite directions from the central portion. The central portion assumes a linear configuration and the extremity portions extending from the central portion assume configurations in which first parts of the extremity portions proximate the central portion curve towards one another and towards the central portion and second parts of the extremity portions relatively more remote from the central portion curve away from one another and from the central portion to position arcuate tips of the extremity portion sufficiently skew to the central portion that tissue around the periphery of the aperture which is punctured by the extremity portions is retained between the tip portions as the clip relaxes.
In yet another of its aspects this invention provides apparatus for closing an aperture such as a vascular aperture resulting from insertion of a surgical instrument into where the apparatus includes a telescoping tubular housing and clip apparatus resident within the housing for closing the aperture. In this aspect of the invention, the clip apparatus preferably includes a plurality of elongated strands with each strand having a central portion and extremity portions extending from the central portion. Tips of the extremity portions remote from the central portion are shaped to retain aperture peripheral tissue encountered thereby. The extremity portions have memory characteristics seeking to cause the extremity portions to curl towards and about the central portion of a respective strand when the strand is in an unconstrained disposition, free of externally applied stress.
In this aspect of the invention, the clip preferably further includes a band circumferentially enveloping the strands proximate the longitudinal midpoints thereof for retaining the strand midpoints in close proximity to one another as the tip portions curl towards and about the midpoints. In this aspect of the invention, the clip preferably further includes a longitudinally elongated member extending from the central portions of the strands substantially in the longitudinal direction with respect thereto and serving to facilitate gripping and guiding of the strand portions of the clip member. The strands, the band and the longitudinally elongated member are preferably bonded together integrally and reside in a housing. The housing is operable to dispense the clip from one end upon relative movement between telescoping sections of the housing.
In another aspect of the invention the housing may be tubular but not telescoping.
When the housing is telescoping, the housing may include at least two (2) telescoping sections and may operate to dispense the clip in a two (2) stage operation in which first relative movement between the telescoping sections results in a first portion of the clip being dispensed from the housing and additional relative movement between the telescoping section results in the remaining portion of the clip being dispensed from the housing.
In this aspect of the invention, the clip may further include a filament, positioned within the housing, connecting the clip to the housing with the filament preferably being connected to a longitudinal member portion of the clip. The filament is preferably flexible.
In this aspect of the invention, the longitudinal member portion of the clip preferably includes a loop formed therein thereby presenting a transverse passageway through the longitudinal member.
The housing preferably further includes a safety member for precluding second telescoping movement of the telescoping sections of the housing after the first telescoping movement until a safety member has been released.
In yet another of its aspects, this invention embraces a method for closing a vascular or other aperture resulting from, for example, insertion of the surgical implement thereinto subsequent to the completion of invasive therapeutic procedure and withdrawal of the implement from the aperture. The method includes providing an elongated strand comprising a central portion and extremity portions extending from the central portion with tips of the extremity portions remote from the central portion being shaped to retain aperture peripheral tissue encountered thereby with the extremity portions having memory characteristics seeking to cause the extremity portions to curl towards and over one another about the central portions when the strand is in an unconstrained disposition, free of externally applied stress.
The method further embraces dispensing the elongated strand from a tubular housing partially into the lumen aperture sufficiently far for the dispensed portion, consisting of the strand from an extremity to a central portion, to curl about and towards the strand central portion thereby to encounter tissue positioned immediately about the periphery of the aperture and to draw the aperture peripheral tissue radially inwardly relative to a longitudinal axis of the strand. In this aspect of the invention the method further embraces dispensing the remaining portion of the strand from a housing thereby permitting the remaining portion of the strand, from the central portion to a second strand extremity, to curl about and towards the central to of the vessel and drawing surrounding subcutaneous fascia radially inwardly relative to the longitudinal axis of the strand thereby substantially augmenting closure of the vessel, puncture site of the vessel external compression.
In yet another of its aspects this invention in a preferred embodiment provides clip apparatus for closing an aperture in tissue where the apparatus includes a first portion forming an arc, a second portion extending transversely from the first portion relative to the arc and a third portion extending from the second portion remotely from the first portion, with the third portion curving progressively relative to the second portion initially towards the first portion and then towards the second portion with a tip of the third portion being adapted for piercing and retaining tissue encountered thereby. In this aspect the invention further preferably includes at least two third portions extending from the second portion at a common position with the third portions curving progressively first towards the first portion and then towards the second portion and each other.
In this aspect the invention may further embrace clip apparatus having a pair of second portions respectively connected to parts of the first portion separated by the arc and extending transversely to the arc in a common direction relative thereto with a pair of third portions extending from respective ones of the second portions, curving progressively first towards the first portion and then simultaneously towards the second portion and each other.
In this aspect of the invention extremities of the third portions desirably contact the second portions, the second portions are preferably linear and the curved segments of the third portions are preferably separated by linear segments.
In this aspect of the invention the first portion is preferably configured as a figure eight.
In this aspect of the invention the second portion preferably extends away from the first portion perpendicularly to a plane of the arc.
When the first portion is configured as a figure eight the second portion preferably extends away from the center of the figure eight configuration.
In this aspect of the invention the first portion further preferably has at least two arcs separated by a straight segment. Further, at least one of the arcs preferably subtends an angle of greater than one hundred eighty degrees.
Still further, the arcs preferably each have straight segments adjoining the ends of the arcs and connecting with the second portions. In this aspect of the invention both of the arcs preferably subtend an angle of greater than one hundred eighty degrees. The second portions are preferably straight and the linear segments of the third portions are preferably straight.
In another aspect this invention provides apparatus for closing an aperture in tissue where the apparatus includes an elongated unitary strand having a central portion and extremity portions extending from the central portion. Tips of the extremity portions remote from the central portion are preferably pointed to engage and retain tissue encountered thereby. The strand is preferably configured so that the tips are at ends of respective curved portions and face towards one another when the clip is in an unconstrained state, free of internal stresses. The strand preferably has a memory characteristic causing the clip, when unconstrained, to seek to return to an unstressed state with the tips seeking to draw together sufficiently to retain tissue engaged by the tips for closing the aperture and retaining the subcutaneous tissue at the exterior surface of the aperture causing external compression by the tips.
In this aspect of the invention the strand preferably further includes a pair of mid-portions intermediate the tips and the central portion with the central portion disposed in a first plane and the mid-portion disposed in a plane transverse to the first plane. The mid-portion preferably has a linear part connected to the central portion and extending transversely therefrom.
Preferably, the central portion is configured to have at least one loop subtending an angle of at least about 180 degrees.
In this aspect of the invention the loop is preferably closed by overlap of the strand upon itself, the central portion preferably lies in a plane, the extremity portions are preferably in a plane transverse to the plane of the central portion and the tips are preferably at ends of the curved portions of the strand, with the tips being closer to the central portion than to the curved portions of the strand supporting the tips.
In this aspect of the invention an upper portion of the apparatus is preferably configured as a figure eight. This apparatus aspect of the invention further has the strand preferably having a mid-portion intermediate the tips and the central portion, extending transversely to the central portion with the tips facingly opposing one another on either side of the mid-portion and pointing away from the central portion in a common direction. The mid-portion is preferably perpendicular to the central portion; the central portion preferably includes a plurality of loops.
In this aspect of the invention the strand is preferably metal and is most preferably a filament. The strand may include at least two filaments.
In this apparatus aspect of the invention the central portion may include at least two preferably co-planar loops.
In another aspect, this invention provides apparatus for inserting a surgical clip which is housed therewithin into tissue to close an aperture in the tissue where the apparatus includes a first handle portion housing a tubular member and having a hand grip extending transversely therefrom where the tubular member is connected to the handle portion and extends generally longitudinally from the handle portion. Surgical clip positioning means are preferably provided at a distal end of the tubular member remote from the handle. A clip loading wire is preferably provided looping around the clip, residing at least partially within the tubular member at a distal end thereof, extending along the length of the tubular member and exiting from the handle portion at a proximate end of the tubular member. The apparatus preferably further includes a clip pusher member movable axially within the tubular member through a range of motion from a first through an intermediate to a second position for displacing the clip from within the tubular member in two stages. The clip is housed within the apparatus and is ready for insertion into the lumen when the pusher member is at the first position. The clip extends partially from the tubular member when the pusher member is at the intermediate position; the clip is separated from the apparatus and presumably within the tissue of interest closing the targeted aperture when the pusher member is at the second position.
In this aspect of the invention the surgical clip insertion apparatus preferably further includes a ring connected to the wire with the ring being detachably mounted on the handle portion at the proximate end of the tubular member. The ring facilitates hand powered movement of the loading wire to draw the clip at least partially into the tubular member.
Preferably in this aspect of the invention the clip positioning means serves to position the clip angularly within the tubular member; most desirably the clip positioning means are slots formed in the tubular member with the slots communicating with the distal end of the tube. Most desirably the slots correspond in number to the number of tissue penetrating points of the surgical clip housed within the apparatus. Further desirably the clip positioning means served to position the surgical clip longitudinally within the tubular member.
In yet another aspect the invention provides apparatus for inserting a surgical clip into tissue to close an aperture in tissue where the apparatus includes a first handle portion, a tubular member connected to the handle portion and extending generally transversely therefrom, a clip loading member pivotally connected to the tubular member and moveable between positions at which the clip is loaded into the apparatus and at which the clip is housed within the apparatus and ready for insertion into the tissue and a clip trigger member which is moveably axially within the tubular member through a range of motion from a first through an intermediate to a second position for displacing the clip from the tubular member in two stages. The clip is desirably housed within the apparatus and ready for insertion into tissue when the trigger is at the first position. The clip preferably extends partially from the tubular member when the trigger is at the second position. The clip is preferably separated from the apparatus and presumably inserted into tissue and closing the aperture of interest when the trigger is at the third position.